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BC1 cell line · 1 trial · 6 indications
Total number of AEs
To evaluate the safety of BC1 as assessed by: o The Proportion of Patients with Abnormalities in Safety Laboratory Parameters
To evaluate the safety of BC1 as assessed by: o Electrocardiograms (ECG) with measurement of the QT interval
To evaluate the safety of BC1 as assessed by: o The Proportion of Patients with Abnormalities in Physical Examination Findings and Abnormal Vital Signs
| Arm | Type | Description |
|---|---|---|
| Phase 1, Part 1 Monotherapy Phase | EXPERIMENTAL | Subject 1, Q2w for 4 doses Subject 2, Q2w for 4 doses Subject 3, Q2w for 4 doses Treatment is administered every 2 weeks for a total of 4 doses. Initially, safety will be assessed on these 3 subjects. DLTs are defined as CTCAE Grade 3 or 4 adverse events that are suspected to be possibly related to study treatment. If 1 of 3 Phase 1 subjects experience a DLT, that dose cohort will be expanded to another 3 patients before the combinational phase begins. A total of 3-6 subjects will be assessed for safety. |
| Phase 1, Part 2 Combination Phase | EXPERIMENTAL | 3 subjects will be treated every 3 weeks with the Bria-OTS regimen with a CPI (tislelizumab) in the Part 2 combination phase. The Bria-OTS regimen consists of cyclophosphamide 300 mg/m2 2-3 days prior to BC1 cell line inoculation. On the same day as the cell inoculation, subjects will receive peginterferon alpha-2a. Subjects will also receive the CPI (tislelizumab) on the same day of the cell inoculation according to approved dosing. Treatment is administered every 3 weeks in combination with the Bria-OTS regimen and CPI (tislelizumab). |
| Phase 2 Expansion Cohort | EXPERIMENTAL | Once 3 patients have been safely treated with the Bria-OTS regimen and CPI (tislelizumab) for 2 cycles, Phase 2 will enroll an expansion cohort, consisting of up to an additional 9 subjects (for a total of 12 treated with the Bria-OTS regimen and CPI). The Bria-OTS regimen consists of cyclophosphamide 300 mg/m2 2-3 days prior to BC1 cell line inoculation. On the same day as the cell inoculation, subjects will receive peginterferon alpha-2a. Subjects will also receive the CPI (tislelizumab) on the same day of the cell inoculation according to approved dosing. Treatment is administered every 3 weeks in combination with the Bria-OTS regimen and CPI (tislelizumab). |
| Name | Type | Description |
|---|---|---|
| BC1 cell line | BIOLOGICAL | BC1 cell line is a different experimental, HER-2 positive, allogeneic, whole cell BC cell lines designed to secrete GM-CSF in situ and augment dendritic cell activity. Similar to the SV-BR-1-GM cell line (NCT03328026, IND 10312), the BC cell line is derived from the BC parent cell line, SV-BR-1, which expresses multiple tumor associated antigens (TAAs) |
| Bria-OTS regimen and CPI (tislelizumab) | BIOLOGICAL | Biological: BC1 * BC1 inoculation intradermally at 4 sites Drug: Low dose cyclophosphamide * Pretreatment with low dose cyclophosphamide 2-3 days prior to BC1 inoculation Drug: Interferon * Subjects will receive low dose peginterferon alpha-2a on the same day as cell inoculation. Drug: Tislelizumab * CPI treatment will also be given on the same day as cell inoculation. |
| Bria-OTS regimen and CPI (tislelizumab) expansion cohort | BIOLOGICAL | Biological: BC1 * BC1 inoculation intradermally at 4 sites Drug: Low dose cyclophosphamide * Pretreatment with low dose cyclophosphamide 2-3 days prior to BC1 inoculation Drug: Interferon * Subjects will receive low dose peginterferon alpha-2a on the same day as cell inoculation. Drug: Tislelizumab * CPI treatment will also be given on the same day as cell inoculation. |
Key Inclusion Criteria: 1. Histological confirmed recurrent metastatic breast cancer which has failed prior therapy defined as: 1. Human epidermal growth factor 2 (EGFR2, HER2) positive tumors must have failed therapy with at least 2 anti-HER2 agents 2. HER2 negative and either ER or PR p...
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BC1 cell line is an investigational cellular immunotherapy being studied for the treatment of breast cancer, specifically in patients with metastatic recurrent breast cancer. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
BC1 cell line is being developed by BriaCell Therapeutics Corp., a biopharmaceutical company traded on the stock exchange under the ticker symbol BCTX. The company is conducting clinical research to evaluate this investigational therapy for breast cancer.
BC1 cell line is currently in Phase 1 clinical development. It is an investigational therapy, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is designed to evaluate its safety and preliminary efficacy in patients with metastatic recurrent breast cancer.
BC1 cell line is being evaluated in a Phase 1 clinical trial registered as NCT06471673, titled "A Study of BRIA-OTS Cellular Immunotherapy in Metastatic Recurrent Breast Cancer." This trial is enrolling approximately 18 participants in the United States and includes adult patients with breast cancer.
BC1 cell line is associated with the investigational cellular immunotherapy referred to as BRIA-OTS in clinical trial NCT06471673. The trial title specifically mentions BRIA-OTS Cellular Immunotherapy, indicating that BC1 cell line may be the same product or a component of this immunotherapy being studied for metastatic recurrent breast cancer.